Ann: Positive Results for Australian Prospective Paediatric Study, page-335

There is still a lot of uncertainty with the US results that is about to come out. Based on the Australian results, as touched on by Southoz, Largeraj and Patto66, for pneumonia the lower confidence limit is at 75%, which is right at the line.
The company needs the lower bound of the 95% confidence interval of both PPA and NPA with clinical diagnosis to be above 75%. Since there is almost no margin for error for the Pneumonia results, the chance of US result being below 75% for lower confidence limit is relatively high. So what is going to happen if the lower confidence limit for Pneumonia is below 75%? Do we need to conduct another clinical trial?